Liraglutide reduces BMI by about 6% in children aged 6 to 12 years

of GlucagonGLP-1 receptor agonists Liraglutide It is the first in its class to be proven effective in infants and young children. obesityAccording to the results of Phase 3a SCALE-KIDS Study Announced European Association for the Study of Diabetes (EASD) Annual Meeting 2024 and Simultaneous release of New England Journal of Medicine.

After one year of treatment, children who received daily liraglutide injections had a 5.8% reduction in body mass index (BMI), while children who received a placebo had a 1.6% increase in BMI. Nearly half of the children who received liraglutide had a reduction in BMI of at least 5%.

Although body fat was not directly measured in the study, children who took liraglutide also had slightly improved diastolic blood pressure. A1c.

The authors acknowledge that there is no consensus on what constitutes a clinically meaningful change in children's BMI, but note that a 5% reduction is associated with improvements in obesity-related health outcomes.

In severely obese children, BMI corresponds “fairly well” to body fat percentage, the lead author says. Claudia Fox, MD, MPHCo-Director of the Center Childhood Obesity He is an MD from the University of Minnesota Medical School. Medscape Medical News.

“I believe this reduction in BMI is likely to translate into a significant reduction in body fat mass,” said Fox, who is also an associate professor in the school's department of pediatric gastroenterology, hepatology and nutrition.

But because body composition wasn't measured, “we cannot rule out the possibility that muscle mass was lost, at least initially,” say Timothy Barrett, MBBS, PhD, and Julian Hamilton-Shields, MBChB, MD, from the School of Medicine at the University of Birmingham and Bristol Medical School at the University of Bristol, UK. Accompanying editorial.

Barrett and Hamilton-Shields further disagree with Fox, pointing out that “we know that BMI is a poor proxy for fat mass.”

Still, the editorialists acknowledged that the trial's “reduction in BMI standard deviation score of 0.7 in the liraglutide arm is likely to improve metabolic variables such as: Insulin Susceptibility and fatty liver.”

U.S. Food and Drug Administration (FDA) Liraglutide approved In 2020, the FDA announced that it would target young people aged 12 to 17. Approved GLP-1 agonists Semaglutide (Wegovy, Novo Nordisk) is approved for the same age group in 2023. However, no GLP-1 agonists are approved for children under 12 years of age.

Liraglutide could offer a new treatment for young children, Fox said. “Kids with severe obesity are in desperate need of treatment,” he said, noting that for many, getting more exercise or changing their diet isn't the answer.

Fox said the patient Fatty liver Illness and High blood pressure When I was 9 and 10 suicide Attempted suicide due to bullying.

Trial Details

Of a total of 82 children, 56 were randomized to liraglutide and 26 to placebo. Children weighing more than 45 kg started on liraglutide 0.6 mg daily for the first week and increased by 0.6 mg per week for up to 8 weeks to reach a final dose of 3 mg once daily. Children weighing less than 45 kg received a starting dose of 0.3 mg and increased by 0.6 mg per week for 10 weeks to reach a maximum dose of 3 mg.

At the end of the study, patients who received liraglutide had gained 1.6% weight compared with 10% for those who received placebo.

Additionally, patients taking liraglutide experienced a 1.7mmHg and 1.2mmHg reduction in systolic and diastolic blood pressure, respectively, and a reduction in HbA1c of about 0.2%, Fox reported.

However, she noted that the children did not have high blood pressure at baseline and the changes in A1c were minimal, urging caution in interpreting these results.

Susma Shanti Vaidya, MD, MPHDr. Gregory B., a pediatric obesity specialist at Children's National Hospital in Washington, D.C., who was not involved in the study, said the weight gain is not a cause for concern.

“Overall there was a slight increase in weight, but they were young children and their growth rate outpaced that, so their BMI went down,” she said. Medscape Medical News.

“Improvements in cardiometabolic parameters” are encouraging, she added.

As seen in trials of GLP-1 agonists in teenagers and adults, gastrointestinal side effects were common in this study.

According to Fox, 45 of the 56 children (80%) who received liraglutide experienced gastrointestinal adverse events, which occurred primarily during the dose-escalation phase of the study. Three serious adverse events thought to be drug-related included two cases of vomiting and one case of vomiting. ColitisSix patients (11%) who received liraglutide discontinued the medication due to side effects.

Interestingly, 14 of 26 people (54%) who took the placebo also reported gastrointestinal symptoms, Fox added.

Are daily injections a hurdle?

Both Fox and Vaidya noted that daily injections can be difficult for children, especially young ones.

But because the needles in the injection pens are so small, Vaidya says many patients quickly get over their fear of injections.

Dr Fox said she initially thought it would be difficult to get parents and children to take part in the study because of the injections, but “we had no choice but to say no”.

“There's such a big need out there,” she said.

Vaidya agreed: “We have a lot of patients under the age of 12 who really need other drug therapy options,” she said.

“Although further research is needed, the results reported by Fox et al. provide much-needed evidence of the effectiveness of GLP-1 receptor agonists in obese young children and offer a treatment option for severely obese prepubertal children as an adjunct to healthy lifestyle interventions,” Barrett and Hamilton-Shields wrote.

The doctors said the treatment is unlikely to become widely available because insurers won't cover it unless it's for an FDA-approved indication.

Novo Nordisk is Medscape Medical News Based on the study results, the company has submitted an application to the FDA for approval of liraglutide for children aged 6 to 12 years with obesity.

This study was funded by Novo Nordisk. Fox discloses that he is an investigator for Eli Lilly and Novo Nordisk but has not received any fees or honoraria. Vaidya reports no relevant financial relationships.

Alicia Ault is a freelance journalist based in St. Petersburg, Florida, whose work has appeared in publications such as JAMA and Smithsonian.com. You can find her at @aliciaault.